The Clinical Efficacy of DFPP in Patients With AAGN

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis Clinical Trial

Official title:

A Prospective, Controlled Study of Double Filtration Plasmapheresis (DFPP) in Patients With Antineutrophil Cytoplasmic Autoantibody Associated Glomerulonephritis (AAGN)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02294344
• Other study ID #: NJCT1403
• Status: Terminated
• Phase: N/A
• First received: June 3, 2014
• Last updated: February 2, 2018
• Start date: June 2014
• Est. completion date: April 2017

Study information

• Verified date: February 2018
• Source: Nanjing University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The clinical efficacy of double filtration plasmapheresis(DFPP) in patients with antineutrophil cytoplasmic autoantibody associated glomerulonephritis(AAGN).

Description:

This is a single center, prospective, randomized,controlled study to compare the clinical efficacy of double filtration plasmapheresis (DFPP) combined with intravenous cyclophosphamide (IV-CTX) pulse therapy versus IV-CTX pulse therapy in patients with antineutrophil cytoplasmic autoantibody associated glomerulonephritis(AAGN).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• a diagnosis of ANCA associated vasculitis(AAV), using criteria adapted from the disease definitions of the Chapel Hill consensus conference

• serum positive ANCA and the ANCA level =100 relative unit/ml

• with renal involvement and serum creatinine=3 mg/dl

• written informed consent had been provided.

Exclusion Criteria:

• other secondary vasculitis

• anti-glomerular basement membrane(GBM) positive

• severe infection; hepatitis B antigenemia, anti- hepatitis C virus

• immunodeficiency; or immunoglobulin G(IgG)<2g/l

• life threatening

• renal biopsy show globally sclerotic glomeruli>60% and normal glomeruli<10%

• need renal replacement therapy for more than 4w

• received large dose of methylprednisolone(MP),CTX,mycophenolate mofetil(MMF), plasmapheresis or intravenous immunoglobulin(IVIg) therapy.

Related Conditions & MeSH terms

• Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
• Vasculitis

Intervention

Other:
• DFPP&CTX
First,patients received methylprednisolone pulse therapy followed by oral prednisone and intravenous cyclophosphamide (IV-CTX) pulse therapy. Then double volume of plasma was processed during each DFPP session every two day. A fraction plasma separator(Asahi Kasei Medical, surface area 2.0 m2,pore size 0.03 mm)and another fraction plasma separator (Asahi Kasei Medical, surface area 2.0 m2, pore size 0.01 mm)were used as first and second filter for plasma fractionation, respectively. 1.5 volume of plasma was processed, and 35~45g human albumin and blood plasma was supplemented during each session. The patients were treated with DFPP every two days for at least 3 times. After DFPP, 300-500ml blood plasma was supplemented.

Drug:
• CTX
First,patients received methylprednisolone pulse therapy followed by oral prednisone and intravenous cyclophosphamide (IV-CTX) pulse therapy. After three months therapy, if the renal function was not recover, the patient would be withdrawn from the study. The other patients after CTX pulse therapy for 6 months and achieve remission to receive oral maintenance therapy with azathioprine (AZA). The dosage of AZA was 1.0-2.0mg/kg/d(more than 50mg/d) and adjusted by white cell count and liver enzyme. If white cell count <3×109/L or an increase in liver enzyme to more than twice the normal upper limit, the dosage of AZA should be reduced. If white cell count <3×109/L or liver enzyme increased repeatedly, the patient would be withdrawn from the study.

Locations

Country	Name	City	State
China	Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Zhi-Hong Liu, M.D.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	the antineutrophil cytoplasmic antibodies(ANCA) level at 12 month		12 months
Other	relapse defined by birmingham vasculitis activity score(BVAS) increased more than 1.0 at 12 month		12 months
Other	the change of BVAS		12 months
Other	the change of Urine protein		12 months
Other	the change of the count of urine sediment red blood cell		12 months
Other	the change of the count of serum creatinine(SCr )		12 months
Other	the change of estimated glomerular filtration rate(eGFR)		12 months
Other	the vasculitis damage index(VDI) at 12 month		12 months
Primary	the renal recovery rate	the renal recovery rate at 3 mo defined by dialysis independence and the SCr <5mg/dl for the patients needed renal replacement therapy at the basement, or the SCr decreased more than 30% of the baseline and the urine sediment red blood cell less than 50*104/ml for the patients without renal replacement at the basement.	3 months
Secondary	kidney survival	patient and kidney survival at 12 month	12 months